The U.S. Department of Health and Human Services has taken an irregular approach to approving COVID-19 vaccines this year. In turn, Pennsylvania pharmacies have been thrown for a loop— and one lawmaker wants permanent changes to keep things clear in the future.

Drug companies have already mass produced COVID-19 vaccines. Some companies now include warnings about Myocarditis (heart issues) and Pericarditis for males aged 12 to 24 as potential adverse affects.

Even with the product on hand, healthcare businesses like pharmacies wait for “recommendations” from trusted organizations on who should receive the vaccine.

The federal organization tasked with giving vaccine guidance is ACIP- the Advisory Committee on Immunization Practices. 

ACIP had all 17 of its members replaced back in June, part of a rearranging of the department to match the vaccine skepticism of Health & Human Services Secretary Robert F. Kennedy Jr.. With all the turn over, the committee has not released any COVID-19 vaccine guidance at this time. 

“The ACIP is meeting in September, the 18th and 19th. We don’t know what the outcome of those meetings will be so essentially we’re coming into the respiratory season with no recommendations,” said Mitchel Rothholz, a pharmacist and member of the Pennsylvania Pharmacist Association.

Alternatively, last week, the U.S. Food and Drug Administration (FDA) released their safety approval of this year’s COVID-19 vaccine… while also giving clinical guidance. The FDA only recommends the vaccine for people with qualifying health problems, and for people over the age of 65.

There’s wide variety among the qualified health concerns. “Physically inactive” is one thing people can mark. 

Overall, the new limits are a departure from previous years where the vaccine was recommended for almost everyone.

“I would not view this as a hard and fast barrier, but I don’t think we should put people in a position where they have to lie or shade about their medical history,”  said Rep. Arvind Venkat, a Democrat from Pittsburgh who also works as a physician.

The vaccine is released, there’s a federal recommendation… here’s the Pennsylvania catch.

By law, pharmacies in the Commonwealth can only administer vaccines approved by the Advisory Commission on Immunization Practices (ACIP). Even with the FDA policy, pharmacies like CVS said last week they wouldn’t administer COVID-19 vaccines.

“We were asking for the state pharmacy board to help with this, to give some clarity to practitioners who really want to serve their patients and their communities,” Rothholz said.

Pennsylvania’s State Board of Pharmacy had an emergency meeting on Wednesday, Sep. 3. Board members voted to loosen where recommendations are sourced.

“Our Pharmacy Practice Act allows the State Board of Pharmacy to designate other competent authorities to fulfill that obligation for pharmacies,” Venkat said.

Yesterday’s vote allows pharmacies to rely on the FDA approval, as well as guidance from several medical societies, to legally administer vaccines.

“It forestalled an immediate crisis, but I don't think it has clarified this to the extent that all of us would want to see,” Venkat said.

The representative has two bills he is sponsoring that addresses vaccine recommendation in the state. HB1828 mandates insurance coverage of vaccines, allowing companies operating on the state to rely on guidance from Pennsylvania’s Health Department.

Currently, insurance companies are mandated to cover vaccines through the affordable care act, which links recommendations to ACIP.

“From a dollars and cents perspective, its a no brainer to pay for administering vaccines versus paying for someone to be severely ill,” Venkat said, noting that insurance companies have semi publicly said they support mandates to cover vaccines.

“Nothing in this legislation mandates that anyone gets a vaccine. It is simply allowing those who make the personal choice to be vaccinated, that they will have insurance coverage for that vaccination,” Venkat said. “And they will have accessibility for that vaccination where they have previously gotten vaccines in the past."